| CTRI Number |
CTRI/2024/07/069768 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Do AI generate images exposure before the treatment reduces the dental anxiety in children aged 6-12 years. |
|
Scientific Title of Study
|
Does AI generate images exposure before the treatment reduces the dental anxiety in children aged 6-12 years. A cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrushti Dagli |
| Designation |
Post graduate student |
| Affiliation |
College of Dental Sciences Amargadh Bhavnagar |
| Address |
Department of pediatric and preventive dentistry Division P Room
No 6 College of Dental Sciences Bhavnagar Rajkot
Highway Amargadh Tal Sihor Dist Bhavnagar
Bhavnagar
GUJARAT
364210
India |
| Phone |
8160759951 |
| Fax |
|
| Email |
shrushti.dagli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital Kiran D P |
| Designation |
Professor and Head of Department in Pediatric and preventive dentistry |
| Affiliation |
College of Dental Sciences Amargadh Bhavnagar |
| Address |
Department of pediatric and preventive dentistry Division P Room
No 6 College of Dental Sciences Bhavnagar Rajkot
Highway Amargadh Tal Sihor Dist Bhavnagar
Bhavnagar
GUJARAT
364210
India |
| Phone |
7016310949 |
| Fax |
|
| Email |
drskiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shital Kiran D P |
| Designation |
Professor and Head of Department in Pediatric and preventive dentistry |
| Affiliation |
College of Dental Sciences Amargadh Bhavnagar |
| Address |
Department of pediatric and preventive dentistry Division P Room
No 6 College of Dental Sciences Bhavnagar Rajkot
Highway Amargadh Tal Sihor Dist Bhavnagar
Bhavnagar
GUJARAT
364210
India |
| Phone |
7016310949 |
| Fax |
|
| Email |
drskiran@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Dental Sciences Bhavnagar Rajkot Highway Amargadh Tal Sihor Dist Bhavnagar |
|
|
Primary Sponsor
|
| Name |
College of Dental Sciences Bhavnagar |
| Address |
College of Dental Sciences Bhavnagar Rajkot Highway Amargadh Tal Sihor Dist Bhavnagar |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrushti Dagli |
College of dental sciences amargadh |
CODS amargadh
Prediatric and
Preventive Dentistry
Division P Room no 6
Bhavnagar
Gujarat
Bhavnagar
GUJARAT |
8160759951
shrushti.dagli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1: Non AI generated image |
In group 1 non AI generated images from google image search will consist of eye smoothening natural images like waterfall valleys forest snow and sky which will be showing to the children in the waiting area. Subjects will be given 2-5 minutes to view the images. Anxiety will be assess before showing and after completing the visualization of the images with the help of the pulse oximeter and RMS-DAS scale. |
| Intervention |
Group 2: AI generated image |
in group 2, AI generated images from Microsoft copilot will consist of eye smoothening natural images like waterfall valleys forest snow and sky which will be showing to the children in the waiting area. Subjects will be given 2-5 minutes to view the images. Anxiety will be assess before showing and after completing the visualization of the images with the help of the pulse oximeter and RMS-DAS scale. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1. Children age between 6-12 years
2. Children with no past dental experienced
3. Children of both the genders boys and girls
|
|
| ExclusionCriteria |
| Details |
1. Blind children
2. Parent who are not willing to give consent for the study.
3. Mentally retarded children
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment of anxiety before showing the images |
pulse rate and RMS-DAS before showing images |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of the anxiety level after showing images |
assessment of the pulse rate AND RMS DAS after showing images |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be carried out on healthy children aged 6-12 years who will report to the Department of Pediatric and Preventive dentistry, College of Dental Sciences, Amargadh. Written informed consent will be taken before starting the study. A total of 30 healthy children will be taken for study which is divided in to 2 different groups. Further,15 healthy children will be randomly allocate in each group by the block randomization . Sample size will be divided into 2 different groups. Group 1: Non AI generated image (control group) Group 2: AI generated image (experimental group) In group 1, non copyright images will be selected from google image search and it will consist of eye smoothening natural images like waterfall, valleys, forest, snow and sky. In group 2, images will be AI generated from Microsoft copilot base on eye smoothening natural images like waterfall, valleys, forest, snow and sky. Pulse rate and Raghavendre, Madhuri and Sujata digital anxiety scale (RMS-DAS) will be measured before and after showing the images to assess child dental anxiety. In group 1, non AI generated images from google image search, will consist of eye smoothening natural images like waterfall, valleys, forest, snow and sky which will be showing to the children in the waiting area. Subjects will be given 2-5 minutes to view the images. Anxiety will be assess before showing and after completing the visualization of the images with the help of the pulse oximeter and RMS-DAS scale. Similarly in group 2, AI generated images from Microsoft copilot, will consist of eye smoothening natural images like waterfall, valleys, forest, snow and sky which will be showing to the children in the waiting area. Subjects will be given 2-5 minutes to view the images. Anxiety will be assess before showing and after completing the visualization of the images with the help of the pulse oximeter and RMS-DAS scale. |